HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130, United States
NCT Number: NCT06999304
Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Saint Paul, Minnesota, 55130, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Intermittent theta burst - Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Continuous theta burst - Number of pulses per session: 1800 pulses; Pulse frequency in burst: 50 Hertz
Other names: Transmagnetic stimulation, MagVenture
Time frame: baseline
Percentage of participants matched with anomalous parcellations based on one of the 2 top ranked burdensome symptoms/symptom profile. If an anomalous parcellation matching one of the top 2 ranked symptom profiles can be identified in at least 16 out of 20 (80%) of participants, the trial will be considered a success.
Time frame: baseline
Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles
Time frame: baseline
Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen
Time frame: baseline
Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities
Time frame: 4 weeks
Percent of participants who complete 4 out of the 5 treatment visits.
Time frame: 4 weeks
Percent of participants who complete all sessions of treatment.
Time frame: 16 weeks
Frequency of each adverse events.
Time frame: 4 weeks
This survey will be used to understand the subject's experience with TMS and whether they feel it is an acceptable form of treatment. Questions will be both open-ended and quantitative (Likert scale). In this study, participants will be asked about their level of satisfaction with various aspects of the treatment. This survey is not standardized. Scores presented as percent of subject responses. Range: [0-100]. Higher percentage indicates more acceptability to this form of treatment.
Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
Pre-post change in global post-concussion scale - Rivermead Post-Concussion Symptoms Questionnaire (RPQ) from baseline to 4- and 12-weeks post-enrollment. The RPQ consists of 16 questions about symptoms experienced after a head injury, rated on a scale of 0-4. Range [0-64]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse.
Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
Pre-post change in symptom specific profile scale (general anxiety disorder-7 (GAD7)) from baseline to 4- and 12-weeks post-enrollment. The GAD7 is a 7-item anxiety scale that is self-administered, valid, and an efficient tool for screening for GAD and assessing its severity in clinical practice and research. Range: [0-21] A higher score indicates more anxiety. A positive change from pre to post (post score-pre score=change) indicates that anxiety symptoms get worse.
Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
Pre-post change in symptom specific profile scale (speed of forgetting (SoF)) from baseline to 4- and 12-weeks post-enrollment. The SOF quantifies the rate of episodic trace decay without the effects of learning. Content is presented as cue-pair associates and assessed through multiple-choice or verbal recall questions. This test is 8 minutes long.
Range: [0-1]. A higher score indicates more memory impairment. A positive change from pre to post (post score-pre score=change) indicates that memory gets worse.
Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
Pre-post change in Concussion Clinical Profiles Screening (CP) from baseline to 4- and 12-weeks post-enrollment. The CP is a 29 item self report tool to assess clinical profiles associated with concussion. Range: [0-87]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse.
Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
Percent of participants that respond to treatment based on improvement in symptom specific scales at 1- 4- and 12-weeks post-enrollment, defined as either show minimally clinically important difference (MCID) ≥2 SD improvement from baseline at a given timepoint
HealthPartners Institute
Other
Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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